An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
NCT05939414
This study is recruiting at 37 US sites in 23 states, according to its ClinicalTrials.gov record last updated .
Summary
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Oligometastatic Prostate Cancer (OMPC)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 to 100 years
- Sex
- Male
- Healthy volunteers
- Not accepted
- Sponsor
- Novartis Pharmaceuticals
- Last updated on ClinicalTrials.gov
- September 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arkansas · 1
- Highlands Oncology Group · Fayetteville, AR
California · 4
- VA Greater LA Healthcare System · Los Angeles, CA
- Stanford University · Palo Alto, CA
- VA Palo Alto Health Care System · Palo Alto, CA
- UCSF · San Francisco, CA
Colorado · 1
- Rocky Mountain Cancer Centers · Denver, CO
Florida · 2
- Cancer Specialists of North Florida · Jacksonville, FL
- Woodlands Medical Specialists · Pensacola, FL
Georgia · 1
- Piedmont Healthcare · Atlanta, GA
Illinois · 2
- University of Chicago · Chicago, IL
- The Cancer Institute of Alexian Brothers · Elk Grove, IL
Iowa · 1
- Unity Point Clinic · Des Moines, IA
Kansas · 1
- University of Kansas Hospital · Kansas City, KS
Louisiana · 2
- Mary Bird Perkins Cancer Center · Baton Rouge, LA
- East Jefferson Hospital · Metairie, LA
Maryland · 2
- Johns Hopkins Kimmel Com Cancer Ctr · Baltimore, MD
- University of Maryland Medical Ctr · Baltimore, MD
Massachusetts · 2
- Beth Israel Deaconess Med Ctr · Boston, MA
- Dana Farber Cancer Institute · Boston, MA
Michigan · 2
- BAMF Health · Grand Rapids, MI
- William Beaumont Hospital · Royal Oak, MI
Minnesota · 1
- Mayo Clinic Rochester · Rochester, MN
Missouri · 2
- St Louis University · St Louis, MO
- Wash U School of Medicine · St Louis, MO
Nebraska · 1
- The Urology Center PC DBA UroHealth Partners · Omaha, NE
New York · 3
- Memorial Sloan Kettering Cancer Ctr · New York, NY
- Associated Med Professionals of NY · Syracuse, NY
- Montefiore Hospital · The Bronx, NY
North Carolina · 1
- East Carolina University · Greenville, NC
Ohio · 1
- Dayton Physicians · Kettering, OH
Oregon · 1
- Oregon Urology Institute · Springfield, OR
South Carolina · 1
- Carolina Urologic Research Center · Myrtle Beach, SC
Tennessee · 1
- Vanderbilt University Medical Center · Nashville, TN
Texas · 2
- Univ of Texas Southwest Med Center · Dallas, TX
- Rio Grande Urology · El Paso, TX
Virginia · 2
- Virginia Oncology Associates · Norfolk, VA
- Blue Ridge Cancer Center · Wytheville, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.